Cleared Traditional

CELSITE IMPLANTABLE PORT WITH VALVED CATHETER

K993024 · B. Braun of America, Inc. · General Hospital
Mar 2000
Decision
186d
Days
Class 2
Risk

About This 510(k) Submission

K993024 is an FDA 510(k) clearance for the CELSITE IMPLANTABLE PORT WITH VALVED CATHETER, a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II — Special Controls, product code LJT), submitted by B. Braun of America, Inc. (Allentown, US). The FDA issued a Cleared decision on March 13, 2000, 186 days after receiving the submission on September 9, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K993024 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1999
Decision Date March 13, 2000
Days to Decision 186 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5965

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